Gabapentin and Chronic Post Surgical Pain (CPSP)
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|ClinicalTrials.gov Identifier: NCT03867240|
Recruitment Status : Recruiting
First Posted : March 7, 2019
Last Update Posted : July 2, 2019
|Condition or disease||Intervention/treatment||Phase|
|Pain, Postoperative Scoliosis Idiopathic||Drug: Gabapentin Other: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||The Use of Perioperative Gabapentin in Adolescents Undergoing Posterior Spinal Fusion for Idiopathic Scoliosis to Prevent Chronic Postsurgical Pain, a Pilot Study.|
|Actual Study Start Date :||June 25, 2019|
|Estimated Primary Completion Date :||April 2020|
|Estimated Study Completion Date :||April 2020|
Gabapentin is a common neuropathic medication used in the treatment of chronic pain. Gabapentin will be given preoperative and continued for 5 days postoperatively.
Gabapentin (10 mg/kg up to 600 mg) will be given 30 minutes prior to being transported to the operating room. The gabapentin will be in the standard liquid with a concentration of 250mg/5mL. Starting postoperative day 1, patients in the experimental group will receive gabapentin three times daily. Dose of gabapentin will be 100 mg for patients <50 kg and 200 mg for patients > 50 kg. Gabapentin will be continued for 5 days postoperatively. If patients are discharged prior to postoperative day 5, they will be provided with gabapentin for the remainder of their doses upon discharge.
Other Name: Neurontin
Placebo Comparator: Placebo
Control group will receive placebo medication at the same interval with the appropriate number of capsules or liquid for their weight to match the experimental group.
Placebo will be given 30 minutes prior to being transported to the operating room. Placebo will be identically appearing to gabapentin. Starting postoperative day 1, control group will receive placebo medication at the same interval with the appropriate number of capsules or liquid for their weight to match the experimental group. It will be continued for 5 days postoperatively. If patients are discharged prior to postoperative day 5, they will be provided with placebo for the remainder of their doses upon discharge.
- Change in NRS for pain intensity score comparing gabapentin and placebo groups [ Time Frame: Baseline (prior to surgery), at 3 months postoperatively, and at 6 months postoperatively ]Patient's included in the study will rate their current pain using the numerical rating scale (NRS). With the NRS for pain intensity, the child rates their pain on a zero to 10 Likert scale, with zero being no pain and 10 being the most pain imaginable. A NRS > 4/10 at the time of the survey will be considered positive for CPSP.
- Change in FDI score comparing gabapentin and placebo groups [ Time Frame: Baseline (prior to surgery), at 3 months postoperatively, and at 6 months postoperatively ]The functional disability inventory (FDI) is a 15 question self-report inventory that assesses the impact of daily pain on activities at home, school, recreational and social domains. Items are rated on a five-point Likert Scale, ranging from 0 to 4, representing no trouble with the activity up to impossible to do the activity. The scores are tabulated, classifying the patient's function as no to minimal disability (0-12), moderate disability (12-29) or severe disability (30-60).
- Total narcotic requirement in the postoperative period in patients receiving gabapentin versus placebo [ Time Frame: Postoperative period up to 1 month ]Opioid consumption will be tabulated from the postoperative care unit (PACU), across nursing shifts and cumulative amounts per day. IV morphine will be converted to oral morphine equivalents using a 3:1 ratio or IV hydromorphone will be converted to IV morphine using a 5:1 ratio. Oxycodone will be converted to oral morphine equivalents using a 1:1.5 ratio. All cumulative opioids will be reported as oral morphine equivalents.
- Time to ambulation in patients receiving gabapentin versus placebo [ Time Frame: Postoperative period up to 1 month ]Time to ambulation will be recorded.
- First oral intake in patients receiving gabapentin versus placebo [ Time Frame: Postoperative period up to 1 month ]Time to first oral intake will be recorded.
- Time to discharge in each group in patients receiving gabapentin versus standard of care [ Time Frame: Postoperative period up to 1 month ]Time to discharge will be recorded.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03867240
|Contact: Cheryl Hartzell, MDfirstname.lastname@example.org|
|United States, Georgia|
|Children's Healthcare of Atlanta||Recruiting|
|Atlanta, Georgia, United States, 30322|
|Contact: Cheryl Hartzell, MD 404-785-6670 email@example.com|
|Principal Investigator:||Cheryl Hartzell, MD||Emory University|